US2002025981A1PendingUtilityA1

Combination therapy

Assignee: PFIZERPriority: Aug 29, 1997Filed: Oct 10, 2001Published: Feb 28, 2002
Est. expiryAug 29, 2017(expired)· nominal 20-yr term from priority
A61P 7/02A61P 43/00A61P 9/10A61P 9/12A61P 37/04A61P 3/06A61P 9/00A61K 31/225A61K 31/44A61K 31/40A61K 2039/55577A61K 45/06A61K 47/40A61K 31/366A61K 47/26A61K 31/455A61P 11/06
34
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Claims

Abstract

This invention relates to pharmaceutical combinations of amlodipine or a pharmaceutically acceptable acid addition salt thereof and statins or pharmaceutically acceptable salts thereof, kits containing such combinations and methods of using such combinations to treat subjects suffering from angina pectoris, atherosclerosis, combined hypertension and hyperlipidemia and to treat subjects presenting with symptoms of cardiac risk, including humans. This invention also relates to additive and synergistic combinations of amlodipine or a pharmaceutically acceptable acid addition salt thereof and statins or pharmaceutically acceptable salts thereof whereby those additive and synergistic combinations are useful in treating subjects suffering from angina pectoris, atherosclerosis, combined hypertension and hyperlipidemia and those subjects presenting with symptoms of cardiac risk, including humans.

Claims

exact text as granted — not AI-modified
1 . A pharmaceutical composition comprising: 
 a. an amount of amlodipine or a pharmaceutically acceptable acid addition salt thereof;    b. an amount of a statin or a pharmaceutically acceptable salt thereof; and    c. a pharmaceutically acceptable carrier or diluent; provided that said statin is not atorvastatin or a pharmaceutically acceptable salt thereof.    
     
     
         2 . A pharmaceutical composition of  claim 1  wherein said statin is simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin; or a pharmaceutically acceptable salt of simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin.  
     
     
         3 . A pharmaceutical composition of  claim 2  wherein said statin is simvastatin, pravastatin, mevastatin, lovastatin or pharmaceutically acceptable salts thereof.  
     
     
         4 . A pharmaceutical composition of  claim 3  comprising amlodipine besylate.  
     
     
         5 . A first pharmaceutical composition for use with a second pharmaceutical composition for achieving a antihypertensive effect and a hypolipidemic effect in a mammal suffering from hypertension and hyperlipidemia, which effects are greater than the sum of the antihypertensive and hypolipidemic effects achieved by administering said first and second pharmaceutical compositions separately and which second pharmaceutical composition comprises an amount of amlodipine or a pharmaceutically acceptable acid addition salt thereof and a pharmaceutically acceptable carrier or diluent, said first pharmaceutical composition comprising an amount of a statin or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier or diluent; provided that said statin is not atorvastatin or a pharmaceutically acceptable salt thereof.  
     
     
         6 . A composition of  claim 5  wherein said statin is simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin; or a pharmaceutically acceptable salt of simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin.  
     
     
         7 . A composition of  claim 6  wherein said second pharmaceutical composition comprises amlodipine besylate.  
     
     
         8 . A first pharmaceutical composition for use with a second pharmaceutical composition for achieving a antihypertensive effect and a hypolipidemic effect in a mammal suffering from hypertension and hyperlipidemia, which effects are greater than the sum of the antihypertensive and hypolipidemic effects achieved by administering said first and second pharmaceutical compositions separately and which second pharmaceutical composition comprises an amount of a statin or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier or diluent, said first pharmaceutical composition comprising an amount of amlodipine or a pharmaceutically acceptable acid addition salt thereof and a pharmaceutically acceptable carrier or diluent, provided that said statin is not atorvastatin or a pharmaceutically acceptable salt thereof.  
     
     
         9 . A composition of  claim 8  wherein said statin is simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin; or a pharmaceutically acceptable salt of simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin.  
     
     
         10 . A composition of  claim 9  comprising amlodipine besylate.  
     
     
         11 . A first pharmaceutical composition for use with a second pharmaceutical composition for achieving a antihypertensive effect and a hypolipidemic effect in a mammal suffering from hypertension and hyperlipidemia, which effects are greater than the antihypertensive and hypolipidemic effects achieved by administering said first or second pharmaceutical compositions separately and which second pharmaceutical composition comprises an amount of a statin or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier or diluent, said first pharmaceutical composition comprising an amount of amlodipine or a pharmaceutically acceptable acid addition salt thereof and a pharmaceutically acceptable carrier or diluent; provided that said statin is not atorvastatin or a pharmaceutically acceptable salt thereof.  
     
     
         12 . A composition of  claim 11  comprising amlodipine besylate.  
     
     
         13 . A first pharmaceutical composition for use with a second pharmaceutical composition for achieving a antihypertensive effect and a hypolipidemic effect in a mammal suffering from hypertension and hyperlipidemia, which effects are greater than the antihypertensive and hypolipidemic effects achieved by administering said first or second pharmaceutical compositions separately and which second pharmaceutical composition comprises an amount of amlodipine or a pharmaceutically acceptable acid addition salt thereof and a pharmaceutically acceptable carrier or diluent, said first pharmaceutical composition comprising an amount of a statin or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier or diluent; provided that said statin is not atorvastatin or a pharmaceutically acceptable salt thereof.  
     
     
         14 . A composition of  claim 13  wherein said statin is simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin; or a pharmaceutically acceptable salt of simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin.  
     
     
         15 . A first pharmaceutical composition for use with a second pharmaceutical composition for achieving an antianginal effect in a mammal suffering from angina pectoris, which effect is greater than the sum of the antiangina effects achieved by administering said first and second pharmaceutical compositions separately and which second pharmaceutical composition comprises an amount of a statin or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier or diluent, said first pharmaceutical composition comprising an amount of amlodipine or a pharmaceutically acceptable acid addition salt thereof and a pharmaceutically acceptable carrier or diluent; provided that said statin is not atorvastatin or a pharmaceutically acceptable salt thereof.  
     
     
         16 . A composition of  claim 15  wherein said statin is simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin; or a pharmaceutically acceptable salt of simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin.  
     
     
         17 . A composition of  claim 16  comprising amlodipine besylate.  
     
     
         18 . A first pharmaceutical composition for use with a second pharmaceutical composition for achieving an antianginal effect in a mammal suffering from angina pectoris, which effect is greater than the sum of the antiangina effects achieved by administering said first and second pharmaceutical compositions separately and which second pharmaceutical composition comprises an amount of amlodipine or a pharmaceutically acceptable acid addition salt thereof and a pharmaceutically acceptable carrier or diluent, said first pharmaceutical composition comprising an amount of a statin or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier or diluent; provided that said statin is not atorvastatin or a pharmaceutically acceptable salt thereof.  
     
     
         19 . A composition of  claim 18  wherein said statin is simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin; or a pharmaceutically acceptable salt of simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin.  
     
     
         20 . A composition of  claim 19  wherein said second pharmaceutical composition comprises amlodipine besylate.  
     
     
         21 . A first pharmaceutical composition for use with a second pharmaceutical composition for achieving an antianginal effect in a mammal suffering from angina pectoris, which effect is greater than the antianginal effects achieved by administering said first or second pharmaceutical compositions separately and which second pharmaceutical composition comprises an amount of a statin or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier or diluent, said first pharmaceutical composition comprising an amount of amlodipine or a pharmaceutically acceptable acid addition salt thereof and a pharmaceutically acceptable carrier or diluent; provided that said statin is not atorvastatin or a pharmaceutically acceptable salt thereof.  
     
     
         22 . A composition of  claim 21  comprising amlodipine besylate.  
     
     
         23 . A first pharmaceutical composition for use with a second pharmaceutical composition for achieving an antianginal effect in a mammal suffering from angina pectoris, which effect is greater than the antianginal effects achieved by administering said first or second pharmaceutical compositions separately and which second pharmaceutical composition comprises an amount of amlodipine or a pharmaceutically acceptable acid addition salt thereof and a pharmaceutically acceptable carrier or diluent, said first pharmaceutical composition comprising an amount of a statin or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier or diluent; provided that said statin is not atorvastatin or a pharmaceutically acceptable salt thereof.  
     
     
         24 . A composition of  claim 23  wherein said statin is simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin; or a pharmaceutically acceptable salt of simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin.  
     
     
         25 . A first pharmaceutical composition for use with a second pharmaceutical composition for achieving an antiatherosclerotic effect in a mammal, which effect is greater than the sum of the antiatherosclerotic effects achieved by administering said first and second pharmaceutical compositions separately and which second pharmaceutical composition comprises an amount of amlodipine or a pharmaceutically acceptable acid addition salt thereof and a pharmaceutically acceptable carrier or diluent, said first pharmaceutical composition comprising an amount of a statin or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier or diluent; provided that said statin is not atorvastatin or a pharmaceutically acceptable salt thereof.  
     
     
         26 . A composition of  claim 25  wherein said statin is simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin; or a pharmaceutically acceptable salt of simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin.  
     
     
         27 . A composition of  claim 26  wherein said second pharmaceutical composition comprises amlodipine besylate.  
     
     
         28 . A composition of  claim 27  wherein said antiatherosclerotic effect is manifested by a slowing of the progression of atherosclerotic plaques.  
     
     
         29 . A composition of  claim 28  wherein said progression of atherosclerotic plaques is slowed in coronary arteries.  
     
     
         30 . A composition of  claim 28  wherein said progression of atherosclerotic plaques is slowed in carotid arteries.  
     
     
         31 . A composition of  claim 28  wherein said progression of atherosclerotic plaques is slowed in the peripheral arterial system.  
     
     
         32 . A composition of  claim 27  wherein said antiatherosclerotic effect is manifested by a regression of atherosclerotic plaques.  
     
     
         33 . A composition of  claim 32  wherein said regression of atherosclerotic plaques occurs in coronary arteries.  
     
     
         34 . A composition of  claim 32  wherein said regression of atherosclerotic plaques occurs in carotid arteries.  
     
     
         35 . A composition of  claim 32  wherein said regression of atherosclerotic plaques occurs in the peripheral arterial system.  
     
     
         36 . A first pharmaceutical composition for use with a second pharmaceutical composition for achieving an antiatherosclerotic effect in a mammal, which effect is greater than the sum of the antiatherosclerotic effects achieved by administering said first and second pharmaceutical compositions separately and which second pharmaceutical composition comprises an amount of a statin or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier or diluent, said first pharmaceutical composition comprising an amount of amlodipine or a pharmaceutically acceptable acid addition salt thereof and a pharmaceutically acceptable carrier or diluent; provided that said statin is not atorvastatin or a pharmaceutically acceptable salt thereof.  
     
     
         37 . A composition of  claim 36  wherein said statin is simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin; or a pharmaceutically acceptable salt of simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin.  
     
     
         38 . A composition of  claim 37  comprising amlodipine besylate.  
     
     
         39 . A composition of  claim 38  wherein said antiatherosclerotic effect is manifested by a slowing of the progression of atherosclerotic plaques.  
     
     
         40 . A composition of  claim 39  wherein said progression of atherosclerotic plaques is slowed in coronary arteries.  
     
     
         41 . A composition of  claim 39  wherein said progression of atherosclerotic plaques is slowed in carotid arteries.  
     
     
         42 . A composition of  claim 39  wherein said progression of atherosclerotic plaques is slowed in the peripheral arterial system.  
     
     
         43 . A composition of  claim 38  wherein said antiatherosclerotic effect is manifested by a regression of atherosclerotic plaques.  
     
     
         44 . A composition of  claim 43  wherein said regression of atherosclerotic plaques occurs in coronary arteries.  
     
     
         45 . A composition of  claim 43  wherein said regression of atherosclerotic plaques occurs in carotid arteries.  
     
     
         46 . A composition of  claim 43  wherein said regression of atherosclerotic plaques occurs in the peripheral arterial system.  
     
     
         47 . A first pharmaceutical composition for use with a second pharmaceutical composition for achieving an antiatherosclerotic effect in a mammal, which effect is greater than the antiatherosclerotic effects achieved by administering said first or second pharmaceutical compositions separately and which second pharmaceutical composition comprises an amount of a statin or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier or diluent, said first pharmaceutical composition comprising an amount of amlodipine or a pharmaceutically acceptable acid addition salt thereof and a pharmaceutically acceptable carrier or diluent; provided that said statin is not atorvastatin or a pharmaceutically acceptable salt thereof.  
     
     
         48 . A composition of  claim 47  comprising amlodipine besylate.  
     
     
         49 . A first pharmaceutical composition for use with a second pharmaceutical composition for achieving an antiatherosclerotic effect in a mammal, which effect is greater than the antiatherosclerotic effects achieved by administering said first or second pharmaceutical compositions separately and which second pharmaceutical composition comprises an amount of amlodipine or a pharmaceutically acceptable acid addition salt thereof and a pharmaceutically acceptable carrier or diluent, said first pharmaceutical composition comprising an amount of a statin or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier or diluent; provided that said statin is not atorvastatin or a pharmaceutically acceptable salt thereof.  
     
     
         50 . A composition of  claim 49  wherein said statin is simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin; or a pharmaceutically acceptable salt of simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin.  
     
     
         51 . A first pharmaceutical composition for use with a second pharmaceutical composition for managing cardiac risk in a mammal at risk of suffering an adverse cardiac event, which effect is greater than the sum of the cardiac risk management effects achieved by administering said first and second pharmaceutical compositions separately and which second pharmaceutical composition comprises an amount of a statin or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier or diluent, said first pharmaceutical composition comprising an amount of amlodipine or a pharmaceutically acceptable acid addition salt thereof and a pharmaceutically acceptable carrier or diluent, provided that said statin is not atorvastatin or a pharmaceutically acceptable salt thereof.  
     
     
         52 . A composition of  claim 51  wherein said statin is simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin; or a pharmaceutically acceptable salt of simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin.  
     
     
         53 . A composition of  claim 52  comprising amlodipine besylate.  
     
     
         54 . A first pharmaceutical composition for use with a second pharmaceutical composition for managing cardiac risk in a mammal at risk of suffering an adverse cardiac event, which effect is greater than the sum of the cardiac risk management effects achieved by administering said first and second pharmaceutical compositions separately and which second pharmaceutical composition comprises an amount of amlodipine or a pharmaceutically acceptable acid addition salt thereof and a pharmaceutically acceptable carrier or diluent, said first pharmaceutical composition comprising an amount of a statin or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier or diluent, provided that said statin is not atorvastatin or a pharmaceutically acceptable salt thereof.  
     
     
         55 . A composition of  claim 54  wherein said statin is simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin; or a pharmaceutically acceptable salt of simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin.  
     
     
         56 . A composition of  claim 55  wherein said second pharmaceutical composition comprises amlodipine besylate.  
     
     
         57 . A first pharmaceutical composition for use with a second pharmaceutical composition for managing cardiac risk in a mammal at risk of suffering an adverse cardiac event, which effect is greater than the cardiac risk management effects achieved by administering said first or second pharmaceutical compositions separately and which second pharmaceutical composition comprises an amount of a statin or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier or diluent, said first pharmaceutical composition comprising an amount of amlodipine or a pharmaceutically acceptable acid addition salt thereof and a pharmaceutically acceptable carrier or diluent; provided that said statin is not atorvastatin or a pharmaceutically acceptable salt thereof.  
     
     
         58 . A composition of  claim 57  comprising amlodipine besylate.  
     
     
         59 . A first pharmaceutical composition for use with a second pharmaceutical composition for managing cardiac risk in a mammal at risk of suffering an adverse cardiac event, which effect is greater than the cardiac risk management effects achieved by administering said first or second pharmaceutical compositions separately and which second pharmaceutical composition comprises an amount of amlodipine or a pharmaceutically acceptable acid addition salt thereof and a pharmaceutically acceptable carrier or diluent, said first pharmaceutical composition comprising an amount of a statin or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier or diluent; provided that said statin is not atorvastatin or a pharmaceutically acceptable salt thereof.  
     
     
         60 . A composition of  claim 59  wherein said statin is simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin; or a pharmaceutically acceptable salt of simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin.  
     
     
         61 . A kit for achieving a therapeutic effect in a mammal comprising: 
 a. an amount of amlodipine or a pharmaceutically acceptable acid addition salt thereof and a pharmaceutically acceptable carrier or diluent in a first unit dosage form;    b. an amount of a statin or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier or diluent in a second unit dosage form; and    c. container means for containing said first and second dosage forms; provided that said statin is not atorvastatin or a pharmaceutically acceptable salt thereof.    
     
     
         62 . A kit of  claim 61  wherein said statin is simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin; or a pharmaceutically acceptable salt of simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin.  
     
     
         63 . A kit of  claim 62  comprising amlodipine besylate.  
     
     
         64 . A kit of  claim 61  wherein said therapeutic effect is treatment of hypertension and hyperlipidemia.  
     
     
         65 . A kit of  claim 61  wherein said therapeutic effect is treatment of angina pectoris.  
     
     
         66 . A kit of  claim 61  wherein said therapeutic effect is management of cardiac risk.  
     
     
         67 . A kit of  claim 61  wherein said therapeutic effect is treatment of atherosclerosis.  
     
     
         68 . A kit of  claim 67  wherein said treatment of atheroclerosis slows the progression of atherosclerotic plaques.  
     
     
         69 . A kit of  claim 68  wherein said progression of atherosclerotic plaques is slowed in coronary arteries.  
     
     
         70 . A kit of  claim 68  wherein said progression of atherosclerotic plaques is slowed in carotid arteries.  
     
     
         71 . A kit of  claim 68  wherein said progression of atherosclerotic plaques is slowed in the peripheral arterial system.  
     
     
         72 . A kit of  claim 67  wherein said treatment of atherosclerosis causes the regression of atherosclerotic plaques.  
     
     
         73 . A kit of  claim 72  wherein said regression of atherosclerotic plaques occurs in coronary arteries.  
     
     
         74 . A kit of  claim 72  wherein said regression of atherosclerotic plaques occurs in carotid arteries.  
     
     
         75 . A kit of  claim 72  wherein said regression of atherosclerotic plaques occurs in the peripheral arterial system.  
     
     
         76 . A kit of  claim 63  wherein said therapeutic effect is treatment of hypertension and hyperlipidemia.  
     
     
         77 . A kit of  claim 63  wherein said therapeutic effect is treatment of angina pectoris.  
     
     
         78 . A kit of  claim 63  wherein said therapeutic effect is treatment of cardiac risk.  
     
     
         79 . A kit of  claim 63  wherein said therapeutic effect is treatment of atherosclerosis.  
     
     
         80 . A kit of  claim 79  wherein said treatment of atheroclerosis slows the progression of atherosclerotic plaques.  
     
     
         81 . A kit of  claim 80  wherein said progression of atherosclerotic plaques is slowed in coronary arteries.  
     
     
         82 . A kit of  claim 80  wherein said progression of atherosclerotic plaques is slowed in carotid arteries.  
     
     
         83 . A kit of  claim 80  wherein said progression of atherosclerotic plaques is slowed in the peripheral arterial system.  
     
     
         84 . A kit of  claim 79  wherein said treatment of atherosclerosis causes the regression of atherosclerotic plaques.  
     
     
         85 . A kit of  claim 84  wherein said regression of atherosclerotic plaques occurs in coronary arteries.  
     
     
         86 . A kit of  claim 84  wherein said regression of atherosclerotic plaques occurs in carotid arteries.  
     
     
         87 . A kit of  claim 84  wherein said regression of atherosclerotic plaques occurs in the peripheral arterial system.  
     
     
         88 . A method for treating a mammal in need of therapeutic treatment comprising administering to said mammal 
 (a) an amount of a first compound, said first compound being amlodipine or a pharmaceutically acceptable acid addition salt thereof; and    (b) an amount of a second compound, said second compound being statin or a pharmaceutically acceptable salt thereof;    wherein said first compound and said second compound are each optionally and independently administered together with a pharmaceutically acceptable carrier or diluent; provided that said statin is not atorvastatin or a pharmaceutically acceptable salt thereof.    
     
     
         89 . A method of  claim 88  wherein said statin is simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin; or a pharmaceutically acceptable salt of simvastatin, pravastatin, rivastatin, mevastatin, fluindostatin, velostatin, fluvastatin, dalvastatin, dihydrocompactin, compactin or lovastatin.  
     
     
         90 . A method of  claim 89  comprising amlodipine besylate.  
     
     
         91 . A method of  claim 88  wherein said first compound and said second compound are administered simultaneously.  
     
     
         92 . A method of  claim 88  wherein said first compound and said second compound are administered sequentially in either order.  
     
     
         93 . A method of  claim 90  wherein said first compound and said second compound are administered simultaneously.  
     
     
         94 . A method of  claim 90  wherein said first compound and said second compound are administered sequentially in either order.  
     
     
         95 . A method of  claim 88  wherein said therapeutic treatment comprises antihypertensive treatment and antihyperlipidemic treatment.  
     
     
         96 . A method of  claim 93  wherein said therapeutic treatment comprises antihypertensive treatment and antihyperlipidemic treatment.  
     
     
         97 . A method of  claim 94  wherein said therapeutic treatment comprises antihypertensive treatment and antihyperlipidemic treatment.  
     
     
         98 . A method of  claim 88  wherein said therapeutic treatment comprises antianginal treatment.  
     
     
         99 . A method of  claim 93  wherein said therapeutic treatment comprises antianginal treatment.  
     
     
         100 . A method of  claim 94  wherein said therapeutic treatment comprises antianginal treatment.  
     
     
         101 . A method of  claim 88  wherein said therapeutic treatment comprises cardiac risk management.  
     
     
         102 . A method of  claim 93  wherein said therapeutic treatment comprises cardiac risk management.  
     
     
         103 . A method of  claim 94  wherein said therapeutic treatment comprises cardiac risk management.  
     
     
         104 . A method of  claim 88  wherein said therapeutic treatment comprises antiatherosclerotic treatment.  
     
     
         105 . A method of  claim 93  wherein said therapeutic treatment comprises antiatherosclerotic treatment.  
     
     
         106 . A method of  claim 94  wherein said therapeutic treatment comprises antiatherosclerotic treatment.

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